NA 50-20708Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Bone Screws, MP, Cross-Pin · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34546540602573), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2020Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF SLEEP APNEA AND BLEEDING UNDERWENT A LEFORT 1/BSSO PROCEDURE ON (B)(6) 2020. PATIENT CAME IN FOR FOLLOW UP VISIT COMPLAINING OF SOME PAIN, AND SURGEON NOTICED A CROSS BITE. SURGEON HAD PATIENT SCANNED AND DETERMINED THAT HARDWARE MAY BE LOOSE. SURGEON REMOVED HARDWARE FROM PATIENT¿S RIGHT AND LEFT MANDIBLE, PUT PATIENT IN ARCH BARS TO REESTABLISH OCCLUSION AND FIXATED RIGHT AND LEFT MANDIBLE. PROCEDURE WAS COMPLETED WITH NO ISSUES.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 10504362 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page